Prevention av Autoimmunitet Med Laktobaciller (PAL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04014660|
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : October 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Celiac Disease in Children Type 1 Diabetes Thyroid||Dietary Supplement: Probiotic Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Prevention av Autoimmunitet Med Laktobaciller (in English; Prevention of Autoimmunity With Lactobacilli)|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Probiotic group
The participants in this group are provided with a dietary supplement (capsules) containing freeze dried bacteria (active lactobacilli culture) mixed with corn starch, for daily intake (1 capsule per day).
Dietary Supplement: Probiotic
The probiotic product consists of two different bacterial strains, L.plantarum Heal 9 and L.paracasei 8700:2
Placebo Comparator: Placebo group
The participants in this group are provided with a dietary supplement (capsules) containing corn starch only, for daily intake (1 capsule per day).
Dietary Supplement: Placebo
The placebo supplement consists of corn starch only.
- Autoimmunity [ Time Frame: 12 months ]To study levels of auto-antibodies (tTGA, GADA, IA-2, IAA, ZnT8a, TPOA) genetically at-risk children. (Blood sample will be analyzed for auto-antibodies (tTGA, GADA, IA-2A, IAA, Zn-T8A, and TPOA)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014660
|Contact: Carin Andrén Aronsson, PhD||+46 40 email@example.com|
|Clinical Research Center (CRC), Bldng 60:11||Recruiting|
|Malmö, Sweden, 20502|
|Contact: Carin Andrén Aronsson, PhD +46 40391113 firstname.lastname@example.org|
|Principal Investigator:||Daniel Agardh, PhD||Dep Clinical Sciences, Lund University|